Republic of the PhilippinesDepartment of Health

OFFICE OF THE SECRETARY

29 March 2021

MEMORANDUM CIRCULARNo. 2021 - O00{5

FOR: ALL UNDERSECRETARIES., ASSISTANT SECRETARIES,

SUBJECT:

DIRECTORS OF BUREAUS, REGIONAL OFFICES ANDSERVICES; EXECUTIVE DIRECTORS OF SPECIALTYHOSPITALS, AND NATIONAL NUTRITION COUNCIL;CHIEFS OF MEDICAL CENTERS HOSPITALSSANITARIA AND INSTITUTES; PRESIDENT OF THEPHILIPPINE HEALTH INSURANCE CORPORATION:DIRECTORS OF PHILIPPINE NATIONAL AIDS COUNCILAND TREATMENT AND REHABILITATION CENTERS;AND OTHERS CONCERNED

DOH-NTF JAO No. 2021-0001 Implementing Rules andRegulations of the Republic Act No. 11525 known as “An ActEstablishing the Coronavirus Disease 2019 (COVID-19)Vaccination Program Expediting the Vaccine Procurement andAdministration Process, Providing Funds Therefor, and ForOther Purposes

Attached for your information and guidance is a copy of the DOH-NTF JAO No.2021-0001 entitled “Implementing Rules and Regulations of the Republic Act No. 11525known as “An Act Establishing the Coronavirus Disease 2019 (COVID-19) VaccinationProgram Expediting the Vaccine Procurement and Administration Process, Providing FundsTherefor, and For Other Purposes, dated March 26, 2021.

Dissemination of the information to all concerned is requested.

By Authority of the Secretary of Health:

C. VILLAVERDE, MD, MPH, MPM, CESO Icretary of HealthPolicy and Systems Development Team

Building ft, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 651-7800 Tocal 1108, TTT, PET2, 1113Direct Line: 711-9502; 711-9503 Fax: 743-1829 @ URL: http://www.doh.gov.ph; e-mail: ftduque@doh.gov.ph

DEPARTMENT OF HEALTHNATIONAL TASK FORCE AGAINST COVID-19

MAR 26 2021

JOINT ADMINISTRATIVE ORDERNo. 2021-_ DOO

SUBJECT: Implemeg

Rules and Regulations of Republic Act Noknown _as_ “An Act Establishing the Coronavirus Disease 2019(COVID-19) Vaccination Program Expediting _the__ VaccineProcurement and Administration Process, Providing Funds Therefor,

andForOther

Purposes”.I. RATIONALE

The Coronavirus Disease 2019 (COVID-19) pandemic is the toughest global healthchallenge so far that has affected the whole country and its health system, and strained theresources of the Government. On January 20, 2020, it was declared by the World HealthOrganization (WHO) as a public health emergency of international concern, and was furtherdeclared as a pandemic on March 11, 2020. President Rodrigo R. Duterte issuedProclamation No. 922 declaring a state of public health emergency in the Philippines due toCOVID-19. Subsequently, Proclamation No. 929 declared a state of calamity throughout thecountry due to COVID-19, which was extended by Proclamation No. 1021.

A year after the government declared a state of public health emergency, there aremore than 600,000 reported COVID-19 cases and counting. Increasing cases and challengesto mitigate its spread has been compounded by the presence of COVID-19 variants in thecountry that have made the virus more transmissible. The vaccines developed and theirroll-out is envisioned to complement the various measures in place to curb this health crisis.It then becomes imperative to expedite the procurement and administration of safe andeffective COVID-19 vaccines.

In view thereof, Republic Act (RA) No. 11525, also known as the “COVID-19Vaccination Program Act of 2021”, herein referred to as the “Act”, was signed by PresidentRodrigo R. Duterte on February 26, 2021. The Act authorizes the National Government, andthe Local Government Units (LGUs) to undertake negotiated procurement of COVID-19vaccines, while the private entities including the Philippine Red Cross are authorized toprocure in coordination and cooperation with the DOH and NTF, through the multipartyagreement. It also provides for immunity from lawsuits of certain individuals and includes anindemnity fund to compensate for serious adverse events following immunization (AEFI).The interim Philippine National Deployment and Vaccination Plan for COVID-19 Vaccineswas issued in January 2021 to provide the operational guidelines in the implementation of theCOVID-19 Vaccination Program.

I. OBJECTIVE

This Order aims to provide the IRR of the Act establishing the COVID-19Vaccination Program expediting the vaccine procurement and administration process,providing funds thereof, and other purposes.

Building 1, San Lazaro Compound. Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 8651-7800 loc. 1108, 1113. 1135Direct Line: 8711-9502, 8711-9503: Fax 8743-1829 e URL: hup Auwu.dah gov ph: e-mail :ftdiue Vi dob govph: \\ \

Il. SCOPE AND COVERAGE

This IRR shall apply to all concerned DOH Bureaus and Services, Centers for HealthDevelopment (CHDs), the Philippine Health Insurance Corporation (PhilHealth) and otherattached agencies, Ministry of Health - Bangsamoro Autonomous Region in MuslimMindanao (MOH-BARMM) pursuant to RA No. 11054, or the “Bangsamoro Organic Law”,public and private health facilities, other relevant National Government Agencies (NGAs)who are members of the National Task Force Against COVID-19 (NTF) andinstrumentalities such as the Government Procurement Policy Board (GPPB), InterimNational Immunization Technical Advisory Group (iNITAG), LGUs, private sectors andallothers that are involved in the implementation of the COVID-19 Vaccination Program.

Further, in the spirit of the Act, this covers all procured and donated COVID-19vaccines with valid Emergency Use Authorization (EUA) from the Philippine Food and DrugAdministration (FDA).

IV. INTERPRETATION AND IMPLEMENTATION

This IRR shall be interpreted and implemented pursuant to the Declaration of Policyprovided in Sec. 2 of the Act. This subscribes to undertake the COVID-19 VaccinationProgram through an integrated approach to health development which shall endeavor tomake essential social services available to all people at an affordable cost. The COVID-19Vaccination Program shall be facilitated, initiated, and monitored by the NationalGovernment, through the DOH and the NTF, and other duly constituted authorities andinstrumentalities.

V. DEFINITION OF TERMS

For purposesof the Act and this IRR, the following terms shall be defined as follows:

A. Adverse Event Following Immunization (AEFI) - refers to any untoward medicaloccurrence which follows immunization and which does not necessarily have a causalrelationship with the usage of the vaccine. The adverse event may be any unfavorableor unintended sign, abnormal laboratory finding, symptom, or disease.

B. Ancillary supplies - refer to supplies necessary for the administration of theCOVID-19 vaccines such as, but not limited to needles, syringes (auto-disabed,mixing), safety collector boxes, alcohol prep pads, surgical mask, face shields, gloves,and other personal protective equipment,

C. Certificate of Product Registration (CPR) - refers to a certificate issued by the FDAfor products that have been approved and registered in the Philippines.

D. Coronavirus Disease 2019 (COVID-19) - refers to a disease caused by the SevereAcute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

E. COVID-19 Vaccination Program - refers to the response of the National Governmentin addressing the adverse impact of COVID-I9 through the delivery andadministration of both procured and donated COVID-19 vaccines, management ofAEFIs and indemnification as covered under the Act.

F. Emergency Use Authorization (EUA)- refers to an authorization issued by the FDAfor unregistered drugs and vaccines in a public health emergency. The EUAis not aCPRor a marketing authorization.

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VI.

. Health Technology Assessment Council (HTAC) - refers to the body composed ofhealth experts created within DOH to conduct Health Technology Assessment ofproperties. effects, or impact of health-related technologies, devices, medicines,vaccines, procedures, and all other health-related systems developedto solve a healthproblem, and improve the quality of lives and health outcomes, utilizing amultidisciplinary process to evaluate the clinical, economic, organizational, social,and ethical issues of a health intervention or health technology.

. National Immunization Technical Advisory Group (NITAG)also the interim NITAG(iNITAG)- refers to the advisory body providing guidance to national policy-makersand program managers to enable them to make evidence-based immunization-relatedpolicy and program decisions.

Philippine Red Cross - refers to a voluntary, independent and autonomousnongovernmentalsociety auxiliary to the authorities of the Republic of the Philippinesin the humanitarian field, as set forth in RA No. 10072, or the “Philippine Red CrossAct of 2009.”

Procuring Entity - refers to any branch, constitutional commision, or office, agency,department, bureau, or instrumentality of the government, including, state universitiesand colleges, government owned and/or -controlled corporations, governmentfinancial institutions, and LGUs procuring goods, consulting services andinfrastructure projects, and lease of goods and real estate, including humanitarianorganizations and private entities, among others, authorized to procure COVID-19vaccines as well as goods and services necessary for their storage, transport,deployment and administration.

. Serious Adverse Effects (SAE) - it shall also refer to serious AEFlIs. that uponcausality assessment, is classified as "vaccine product-related reaction" or "vaccinequality defect-related reaction", arising from the use of COVID-19 vaccine. SeriousAEFIs are:

(a) AEFIs that result in any of the following outcomes- death, hospitalization orprolongation of an existing hospitalization, persistent or significant disabilityor incapacity, and congenita! anomaly or birth defect;

(b) AEF Is that may be severe, critical or life-threatening;(c) AEFIs that require intervention to prevent any of the above-mentioned

outcomes; or(d) AEFIs thatare classified by the Department of Health, as recommended by the

National AEFI Committee (NAEFIC), as a medically important event orreaction.

. Third Party Logistics (TPL) - refers to a third party service provider, eithergovernment or private company providing brokerage, storing/warehousing, handlingand distribution services, among others, including software and tracking system forthe vaccine.

GENERAL GUIDELINES

. The COVID-19 Vaccination Program shall follow the guidelines set forth in thepertinent sections of the Act, the Philippine National Deployment and VaccinationPlan for COVID-19 Vaccines, andall relevant existing guidelines.

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B. The National Government, through the DOH, NTF, LGUs and other duly constitutedauthorities and instrumentalities, shall address the adverse impact of COVID-19through the procurement and administration of safe and effective COVID-19vaccines.

C. The DOH and the NTF may enter into a multiparty agreement for the procurement ofCOVID-19 vaccines by LGUs and Private Sector, including goods and servicesnecessary for their storage, transport, deployment and administration, subject tochange and experimental nature of COVID-19 vaccines.

D. Only COVID-1!9 vaccines with valid EUAs issued by the FDA through FDA CircularNo. 2020-036 entitled, “Guidelines on the Issuance of Emergency Use Authorizationfor Drugs and Vaccines for COVID 19”, and with positive recommendations fromHTACshall be procured by the DOH while an FDA-issued CPRis unavailable.

E. Only COVID-19 vaccines procured or donated with a valid EUA issued by FDA shallbe distributed and administered by the DOH, the NTF, LGUs, and other ProcuringEntities including the private sector, as may be recognized in the multipartyagreement, subject to the prevailing guidelines under the COVID-19 VaccinationProgram.

F. The EUA instructions issued by the FDA shall be considered in the judicious planningand allocation tasks of the NTF Vaccine Cluster, in the distribution and programmanagement of the regional and local Vaccine Operations Center (VOC), as well as,in the administration of COVID-19 vaccines by trained healthcare personnel.

G. The identified Priority Eligible Groups, meriting further definition as provided iniNITAG Resolution No. |, Series of 2021, and its succeeding amendments, shall bedefined by the relevant national government agencies, such as, but not limited to, theDepartment of Social Welfare and Development (DSWD), Department of the Interiorand Local Government (DILG), Department of Labor and Employment (DOLE), andthe Department of Trade and Industry (DTI).

H. The Philippine COVID-19 Vaccine Information Management System (VIMS) shall bethe official key process automation, data management system, and data repository ofthe COVID-19 Vaccination Program. The DOH and DICT, together with otherrelevant NGAs, shall publish relevant guidelines regarding the implementation of thePhilippine COVID-19 VIMS.

1. All vaccine recipients shall be monitored for the manifestation of any AEFI andreferred to the appropriate facility for management.

J, Minimum public health standards, including, but not limited to, physical distancing,hand hygiene, cough and sneeze etiquette, wearing of face masks, face shields,engineering, administrative, and PPE controls, among others, shall be strictlyimplemented during the implementation of the COVID-19 Vaccination Program.

VI. SPECIFIC GUIDELINES

A. Procurement of COVID-19 Vaccines and Ancillary Supplies and Services

1. The DOH and the NTF, either through themselves jointly or in cooperationwith any NGA or instrumentality or LGU, or private entity shall be authorizedto procure COVID-19 vaccines, including goods and services necessary for

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their storage, transport, deployment, and administration through theNegotiated Procurement under Emergency Cases modality pursuant to Section53(b) of RA No. 9184 or the “Government Procurement Reform Act” andSection 53.2 of the 2016 Revised IRR of RA No. 9184. The multipartyagreement shall be signed by themselves jointly or in cooperation with anyNGA or instrumentality or LGU or private entity authorized to procureCOVID-19 vaccines.

. The NTF, together with the DOH. shall issue a separate guideline tooperationalize the procedures in the procurement of COVID-19 vaccines forthe Procuring Entities. such as the LGU and theprivate sector consistent withthe guidelines provided in this IRR and in line with the intent of the Act toallow flexibility in the participation of all LGUs and the private sector. Suchguideline shall be posted prominently in the official websites of the DOHathttps://doh.gov.ph/ and the Inter-agency Task Force for the Management ofEmerging Infectious Diseases (LATF-EID) at https://iatf.doh.zov.ph/.

. The NTF. together with the DOH. shall review the requests of LGUs toprocure vaccines to ensure compliance to Section 4 of the Act, stating thatLGUs shall procure no more than seventy-five percent (75%) of their targetpopulation for vaccination; Provided. That the seventy-five percent (75%) capmay be adjusted by the IATF-EID when there ts sufficient supply of vaccinesas determined by the DOH and the NTF.

In the procurement of COVID-19 vaccines, the DOH and the NTF, throughitsTask Group on Procurement and Finance, shall be authorized to negotiate,review, draft, and approve relevant legal documents (e.g. Non-DisclosureAgreement, Term Sheet, Supply Agreement) to ensure that the terms andconditions thereof, in behalf of the National Government, as well as LGUsand other Procuring Entities, including. but not limited to the price andpayment terms,will reflect price uniformity and to prevent price competition.Payment for services such as brokerage, storage, handling, and distributionshall be based on services rendered subject to the agreements between thecontracting parties.

. Notwithstanding RA No. 7160, as amended, or the “Local Government Codeof 1991,” Section 88 of Presidential Decree (PD) No. 1445, as amended,or the“Government Auditing Code of the Philippines,” and other applicable laws, allLGUsand other Procuring Entities authorized to procure COVID-19 vaccinesmay pay, remit, or transfer advance payment if required by the suppliers,manufacturer, or distributor. However, the advance payment shall beapplicable only to COVID-19 vaccines and goods and services necessary fortheir storage, transport, deployment, and administration.

. After the negotiations by the DOH and the NTF, through its Task Group onProcurement and Finance, the LGUs and other Procuring Entities shall beauthorized to enter into supply agreement, advance market commitment,advance payment, research investment. purchase order, or any similararrangements or other requirements as may be identified by the DOH and theNTF, with the pharmaceutical industry through the multiparty agreement. TheDOHand the NTFshall ensure that the multiparty agreement to be signedshall contain the roles and responsibilities of all Parties involved. The NTF incoordination with the DOH shall set the parameters to be included in the legaldocuments in the negotiation for the vaccine purchase agreements.

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7. The LGUs and other Procuring Entities including the private sector shall beauthorized to directly procure goods and services necessary for the storage,transport, deployment, and administration of COVID-19 vaccines, in

accordance with the relevant provisions contained in the Philippine NationalDeployment and Vaccine Plan for COVID-19 Vaccines. The LGUs mayprocure through Negotiated Procurement under Emergency Cases pursuant toSection 53(b) of RA No. 9184 and Section 53.2 of the 2016 Revised IRR ofRA No. 9184, and other relevant guidelines as may be issued by the GPPB.

8. The LGUs and other Procuring Entities, including the private sector shallensure the delivery of their COVID-19 vaccines by contracting the services ofThird Party Logistics (TPL) management providers or providing LGU-ownedtransportation for the delivery of the COVID-19 vaccines to the facilities oftheir choice, pursuant to existing relevant DOH and other government policies.In case the above mentioned conditions are inapplicable, the DOH and theconcemed parties may enter into a separate agreement to ensure the deliveryof vaccines.

9. The preceding provisions (VII.A.1-8) shall have a retroactive application fromJanuary 1, 2021.

10. The LGUsand other Procuring Entities including the private sector shall abideby the DOH Department Memorandum (DM) No. 2021-0116 or the “InterimGuidelines on the Identification and Utilization of COVID-19 VaccinationSites.”

11. No cost of vaccination in the workplace shall be charged against or passed on,directly or indirectly, to the employees (Department of Labor and EmploymentLabor Advisory No. 3 s. 2021! entitled “Guidelines on the Administration ofCOVID — 19 Vaccines in the Workplaces.”)

12. Non-compliance to the EUA, prioritization framework, and vaccineadministration guidelines shall be used as additional consideration in futureallocations and public reporting of performance, which shall be furtherelaborated in subsequent guidelines.

13. In order to preserve the efficacy of the vaccines, the DOH, NTF and theirauthorized representatives shall assist all LGUs and other Procuring Entitiesauthorized to procure or accept the COVID-19 vaccines, in the conduct ofpre-procurement assessment of their available cold room storage facilities,freezers, and equipment ofall health facilities under their jurisdictions, and;designated recipients of the COVID-19 vaccines, as part of their readinessassessment as contained in the Vaccine Introduction Readiness AssessmentTool (VIRAT)of the WHO which|is accessible through the following link:

/iwww.who.on-RA-Tool-2020.1

14. In the absence of the CPR issued by FDA, manufacturers and suppliers ofCOVID-19 vaccines shall be prohibited to sell any COVID-19 vaccinescommercially.

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B. Procurement and Administration of COVID-19 Vaccines and Ancillary Suppliesand Services by LGUs

1. The LGUs may procure only in cooperation with the DOH and the NTFthrough a multiparty agreement which shall include the DOH, NTF and therelevant suppliers of COVID-19 vaccines, through the NegotiatedProcurement under Emergency Cases under Section 53.2 of the 2016 IRR ofRA No. 9184, according to the pre-conditions specified therein, and otherrelevant guidelines as may be issued by the GPPB.

2. Procurement of COVID-19 vaccines by the LGUs shall not exceedseventy-five percent (75%) of their target population for vaccination, incompliance with the provision of Section VIL.A.3 of this Order.

3. The LGUs may directly accept donations of FDA-authorized and clearedCOVID-19 vaccines, subject to the guidelines and reportorial requirements ofthe DOH and the NTF, which give priority to the needs of the followinggroups: healthcare workers (HCWs), senior citizens, persons withco-morbidities, frontline personnel in essential services, and the indigentpopulation, in the order indicated in those guidetines. LGUs shall secure theservices for brokerage, handling, storage, and distribution prior to acceptanceof any vaccine donation.

4. The LGUs and other Procuring Entities, including the private sector, incoordination with the DOH and NTF, shall have secured the services for thefollowing: brokerage, handling, storage and distribution prior to theprocurement of COVID-1I9 vaccines. The LGUs may procure the vaccines,through the Negotiated Procurement under Emergency Cases pursuant to theprovision of the 2016 IRR of RA No. 9184, and other relevant guidelines asmaybe issued by the GPPB.

5. The preceding provisions (VH. B. 1-4) shall have a retroactive applicationfrom January 1, 2021.

6. For National Government-funded vaccines, the LGUs shall comply with thescience and evidence-based terms and conditions of deployment whileprioritizing the needs of the following groups: HCWs, senior citizens, personswith comorbidities, frontline personnel in essential services, and the indigentpopulation.

7. For LGU-funded vaccines, the inoculation order shall, at all times, be scienceand evidence-based while prioritizing the needs of the special groups: frontlineworkersin health facilities, senior citizens, and indigent persons.

8. The focal health officials of the LGU shall be allowed to formulate their ownvaccine recipient list and implement their own operational procedures inaccordance with the national policies and procedures issued by the DOH, suchas the Philippine National Deployment and Vaccination Plan for COVID-19Vaccines and National Vaccine Operations Center advisories, if it will expediteand enhance the efficiency of the inoculation process and prevent the spoilageof vaccines.

9. To ensure transparency, the LGUs shall also submit to the Vaccine InformationManagement System-Immunization Registry (VIMS-IR), a masterlist of thenames and profiles of the residents, including the healthcare workers andqa"

uniformed personnel who were vaccinated under the COVID-19 VaccinationProgram in their area, subject to the provisions of RA No. 10173 orthe “DataPrivacy Act of 2012”, DOH DM No. 2021-0099, and further guidelines to be

jointly issued by DOH and DICT,together with other relevant NGAs.

C. Procurement and Administration of COVID-19 Vaccines by Private Entities

1. Procurement of COVID-19 vaccines by private entities shall be in

coordination and cooperation with the DOH and NTF, through its Task Groupon Procurement and Finance, through the issuance of a multi-party agreementsigned by the supplier/manufacturer, the private entity, and the DOH and NTF.

2. The procured COVID-19 vaccines shall not be for sale but for theexclusive/sole use of the private entities for workers in their businesses or forthe qualified recipient entities, in case of donated COVID-19 vaccines, andthat priority in the inoculation shall be their HC Ws, senior citizens, economicfrontliners, and essential workers.

3. It is only after the inoculation of these groups that they could administer theCOVID-19 vaccines to their other workers qualified or assessed to bevaccinated, free of charge; Provided, That private entities may enter intoarrangements with their workers to allow such workers to designate otherpersons as vaccine recipients subject to the EUA, the multiparty agreementand other applicable issuances.

4. The chief medical officers of the private entities shall be allowed to formulatetheir own vaccine recipient list and implement their own operationalprocedures, in accordance with the national policies and procedures issued bythe DOH suchas the National Deployment and Vaccination Plan and NationalVaccine Operations Center Advisories, if it will expedite and enhance theefficiency of the inoculation process and prevent the spoilage of vaccines.

5. The preceding provisions (VII. C.t-4) shall have a retroactive application fromNovember |, 2020.

6. Duly accredited members and designated staff of diplomatic and consularmissions and international organizations in the Philippines are included in thenational vaccination program.

Accredited missions and international organizations concerned may procurevaccines or receive vaccines intended for them by their respective sendinggovernments or organizations. Said vaccines must have an EUA from the FDAand shall only be intended for use by and administered to, duly accreditedmembers of the diplomatic and consular missions and_ internationalorganizations, as well as their staff, including local hires, and immediatefamily membersof their household in the Philippines.

Towards this end, all accredited missions and international organizations shallsubmit relevant details to the DOH, through the Departmentof Foreign Affairs(DFA), for their integration into the national vaccination program. A reportshall also be submitted to the DOH, through the DFA, regarding the numberofvaccinated individuals based on the numberof vaccines supplied or procuredfor registration in the VIMS-IR and for the requisite monitoring of AEFls, inaccordance with the system of reporting contained in the relevant provisionsof the National Deployment and Vaccination Plan. AN

7. International humanitarian organizations, such as the bodies under the UnitedNations (e.g. WHO) and the Philippine Red Cross, may procure COVID-19vaccines, for the use of individuals consistent with the priority list set. ThePhilippine Red Cross shal! subscribe to its advocacy for every one vaccinebought, one vaccine shall be donated to the vulnerable and indigentpopulation. All engaged international humanitarian organizations shall reportto the DOH, the number of vaccinated individuals based on the number ofprocured vaccines.

8. To ensure transparency, the private sector shall also submit to the VIMS-IR, amasterlist of the names and profiles of their employees including the HCWswho were vaccinated through the multiparty agreement, subject to theprovisions of the 2012 Data Privacy Act, DOH DM No. 2021-0099, andfurther guidelines to be jointly issued by DOH and DICT, and together withother relevant NGAs. The private sector shall! also ensure it subscribes to thesystem of reporting of AEFIs as contained in relevant provisions of theNational Deployment and Vaccination Plan.

9. The DOH, NTF, LGUs, and private entities procuring COVID-19 vaccinesmay coordinate with the Philippine Red Cross in the administration,distribution, and inoculation of their procured vaccines.

D. Transparency and Accountability in COVID-19 Vaccine Procurement

1. The National Government, LGUs, private entities, and the Philippine RedCross shall procure vaccines that are registered with the Philippine FDA asevidenced by a valid EUA, through the multiparty agreement with DOH andNTF.

2. The following information shall be posted in a conspicuous place of theProcuring Entity and in the GPPB online portal within thirty (30) days afteraward or execution of definitive agreement orafter the effectivity of this IRR,whichever is applicable, subject to the terms and conditions of the multipartyagreement entered into by involved parties.

a. Approved budgetfor the contract;b. Name and details of the COVID-19 vaccines or ancillary services or

supplies;c. Nameof the supplier, manufacturer, or distributor; andd. Amountof contract as awarded.

E. Authority to Make Recommendations Based on Preliminary Data from PhaseIIIClinical Trials

1. The HTACshall have the authority to make recommendations to the DOH onthe procurement of COVID-19 vaccines based on the preliminary data fromPhase III clinical trials and the WHO recommendations, in the absence ofcompleted Phase II] and Phase IV clinical trials. The assessment shall beinitiated upon official request of the end-user office.

2. The COVID-19 vaccine shall have been issued an EUA by the FDA.

3. The EUA issuance by the FDA, and HTAC recommendation are two separateprocesses that may be done in parallel to fast-track the review and assessmentof COVID-19 vaccines.

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4. The authority granted to the HTAC herein shall be valid for as long as theEUA issued by the FDAisin effect. In cases where the EUAis either revokedor cancelled, ongoing health technology assessment (HTA) shall be terminatedand completed results are nullified.

The DOH AO 2021-0022 or the “Guidelines on the Facilitation andManagement of Donations to the Health Sector During the COVID-19Pandemic” shall be used as the guiding policy in relation to HTACrecommendations on donated vaccines.

F. Immunity from Liability

Public officials and employees, contractors, manufacturers, volunteers, andrepresentatives of duly authorized private entities who are duly authorized tocarry out and are actually carrying out the COVID-19 Vaccination Programshall be immune from suit and liability under Philippine laws with respect toall claims arising out of, related to, or resulting from the administration or useof COVID-19 vaccines under the COVID-19 Vaccination Program, exceptthose arising from willful misconduct and gross negligence.

G. Pharmacists and Midwives as Vaccinators

Notwithstanding the provisions of RA No. 10918 otherwise known as the“Philippine Pharmacy Act of 2016”, licensed pharmacists may administerCOVID-19 vaccines which are FDA-approved or which possess an EUA,provided that they undergo training on vaccine administration and AEFImanagement by the DOH. The COVID-19 vaccination sites shall require thetraining certificates of the pharmacists before they are allowed to administerCOVID-19 vaccines.

Notwithstanding the provisions of RA No. 7392, or the “Philippine MidwiferyAct of 992”, licensed midwives may administer COVID-19 vaccines whichare FDA approved or which possess an EUA, provided they are duly trainedand certified by the DOH whoshall issue certificates of completion.

Standard training courses on COVID-19 vaccine administration and AEFImanagement shall be provided by DOH through its CHDs and partner agenciesand shall be made available at no-cost to all pharmacists and midwives andother health professionals through online platforms. All DOH courses shall beaccredited by the Professional Regulation Commission as ContinuingProfessional Development (CPD) programs.

H. COVID-19 National Vaccine Indemnity Fund

1.

2.

The COVID-19 National Vaccine Indemnity fund shall be administered byPhilHealth as a trust fund to compensate for any person inoculated through theCOVID-19 Vaccination Program in case of death, permanent disability orhospital confinement for any SAEs.

The amountoffive hundred million pesos (P500,000,000.00) sourced from theContingent Fund, as provided under RA No. 11518 or the “General

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Appropriations Act of 2021”, shall augment the funds of PhilHealth for this

purpose.

Philhealth shall issue relevant implementing guidelines on the availment ofindemnification for death, permanent disability or hospital confinement forany SAEs.

. The indemnity fund shall be valid and available for release and disbursementuntil terminated by the Presidentof the Philippines, based on the finding ofthePermanent Committee. which was created under Executive Order No. 292,s.1987, that the purpose for which the fund has been established has beenfulfilled. The Permanent Committee shall also determine the amount that shallrevert to the National Treasury upon its termination.

The Philhealth, in consultation with the DOH, the Departmentof Finance, theDepartment of Budget and Management and the NTF, shall issue the necessaryguidelines for the planning, administration, and monitoring of the utilization ofthe fund, including the determination of its sufficiency.

The I[ATF-EID shall establish a Special Task Group composed of medical andvaccine experts with proven track record, who will be in charge of monitoringthe probable adverse effects following immunization from COVID-19. TheSpecial Task Group shall promulgate the necessary guidelines on themonitoring, evaluation, investigation, and reporting mechanism to be followedby all LGUs andprivate entities.

This section shall be valid and in effect for a period offive (5) years from theeffectivity of the Act or until the government has declared the completion ofthe COVID-19 Vaccination Program, whichever comes earlier.

Il. Exemption from Import Duties, Taxes and Other Fees for Procurement,Deployment, and Administration of COVID-19 Vaccines

Beginning January 1, 2021, the procurement, importation, donation, storage,transport, deployment, and administration of COVID-19 vaccines through theCOVID-19 Vaccination Program by the government or anyofits politica!subdivisions and by private entities shall be exempt from customs duties,value-added tax, excise tax, donor’s tax. and other fees; Provided, That thevaccines shall not be intended for resale or other commercial use and shall bedistributed without consideration from persons to be vaccinated.

J. COVID-19 Vaccine Card

In the implementation of the vaccination program following relevantprovisions in the Philippine National Deployment and Vaccination Plan, novaccine shall be administered to anyone who has not submitted a signedinformed consent form, pursuant to existing guidelines in DOH DM No.2021-0099 or the “Interim Omnibus Guidelines for the Implementation of theNational Vaccine Deployment Plan for COVID-19.” A standardizedCOVID-1I9 vaccine card shall be issued to vaccine recipients to ensurecompletion of the required doses by documenting details of their vaccination.

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Subject to the provisions of RA 10173 or the “Data Privacy Act of 2012”, theDOH shall issue vaccine cards to all persons vaccinated. To fast track theprocess, the DOH maydelegate the processing and issuance of the vaccinecards to LGUs andprivate entities, subject to guidelines to be promulgated bythe DOH.

The vaccine card shall contain the following information with a template tobe issued by the DOH:

a. Basic personal information such as full name, present and/orpermanent address, andbirthdate;

b. Manufacturer, brand name, batch number, lot number, or otheridentifier of the COVID-19 vaccine;

c. Date and time of vaccination;d. Nameofthe hospital, health center or health facility where the vaccine

was administered;e. Name, signature, and license numberof the duly licensed physician,

nurse, pharmacists, midwives or other health worker administering thevaccine;

f. Date of the last RT-PCR testing and the name of the laboratory thatconducted the last RT-PCR testing, if applicable;

g. Name and details of contact person or person to be notified, in case ofemergency; and,

h. Other information which may be determined as necessary by theSecretary of Health or the IATF-EID.

The issuance of the vaccine card is intended to be digital. The DOH, throughthe DICT, shall develop the LGU-based digital systems and applications thatshall meet the objectives of the COVID-19 Vaccination Program whilemaintaining quality, safety, ease of use, and accessibility for all Filipinos.

The vaccine card shall remain accessible through other means such as printedcards. The vaccine card shall be printed by the facility/LGU in line with theprinting standards/template set by the DOH.

The scheduled date for the second dose, if applicable, shal! be indicated in thesecond dose box in the vaccine card.The DOH shal! maintain a central database of vaccinations, and mandate auniform format for the vaccine card, the contents of which shall be updatedaccordingly to always conform with globally accepted standards.

The vaccine card shall not be considered as an additional mandatoryrequirement for educational, employment, and other similar governmenttransaction purposes.

Individuals vaccinated against COVID-19 as indicated in the vaccine cardshall not be considered immune from COVID-19, unless otherwise declaredby the DOH based onreliable scientific evidence and consensus.

No fees shall be collected for the issuance, amendment or replacement of avaccine card.

. The amount needed for the initial implementation shall be charged againstavailable funds for the purpose. Funds necessary for the continued

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implementation shall be included in the annual General Appropriations Act(GAA).

K. Reportorial Requirement and Creation of an Oversight Committee

1. The Vaccine Czar, the DOH, and the IATF-EID shall submit a monthly reportto Congress on the implementation of the COVID-19 Vaccination Programwhich shall include:

Agreements made by Procuring Entities;Date ofdelivery;Vaccine storage and deployment;Numberof persons vaccinated; and,Other relevant information as may be required.es

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2. The DOH shall develop the template, indicators, and process of submission ofreports to the Congress, which will be issued in separate guidelines.

VIII. RESPONSIBILITIES OF NGAs, NTF, LGUS AND PRIVATE ENTITIES

A. The NTF together with the DOH shall develop supplemental operational guidelineson the procurement of COVID-19 Vaccines for reference of Procuring Entities such asthe LGUs and the private sector, as may be needed consistent with the guidelinesprovided in this IRR and in line with the intent of the Act to allow flexibility in theparticipation of all LGUs and the private sector.

B. PhilHealth shall issue the implementing guidelines covering Section 10 of the Act onCOVID-19 National Vaccine Indemnity Fund to compensate persons encounteringSAEs andother provisions as stated in the section.

C. Cascading of policies related to the COVID-19 Vaccination Program shall befacilitated by the NTF, DOH, Department of the Interior and the Local Government(DILG), Philippine Information Agency (PIA), and other concerned member agenciesof the NTF to ensure that vaccination plans of LGUs and other private entities are inline with the overall vaccination plan of the National Government.

D. The DOH, NTF, LGUs and private entities may partner and coordinate with thePhilippine Red Cross in the administration, distribution, and inoculation ofCOVID-19 vaccines.

E. The GPPB shall issue the guidelines, as may be necessary, on the procurementprocess and transparency requirements under Section 6 of RA No. 11525.

IX. PENAL PROVISION

Falsification of a vaccine card shall be punishable under Act No. 3815 as amended, or“The Revised Penal Code.”

Sale, advertisement, procurement, distribution or administration of COVID-19vaccines without a valid EUA issued, shall be penalized based on the appropriate provisionsof RA No. 9711, or the “Food and Drug Administration Act of 2009,” and other relevantexisting rules, regulations and issuances.

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X. SEPARABILITY CLAUSE

If any part, section or provision of this IRR is held invalid or unconstitutional, theremaining parts or provisions not affected thereby shall remain in full force andeffect.

XI. REPEALING CLAUSE

All orders, rules, regulations, and other related issuances inconsistent with or contraryto this IRR are hereby repealed, amended, or modified accordingly. All other provisions ofexisting issuances whichare not affected by this Order shall remain valid andin effect.

XI. EFFECTIVITY

This Order shall take effect immediately after its publication in the Official Gazette orin any national newspaper of general circulation, with three (3) certified copies to be filedwith the Office of the National Administrative Register (ONAR) of the University of thePhilippines Law Center. This shall remain in full force during jod of state of calamityas declared under Proclamation No. 929, which was ext lamation No. 1021,unless otherwise rescinded or revised.

SE waned T. DUQUE ITI, MSc SEC. CARLITO G. GALVEZ,JR.Department of Health Vaccine Czar, National Task Force

Against COVID-19